Hey, I get it, I was nervous in the beginning too. There’s nothing wrong with being nervous and asking questions, as long as you’re willing to follow up those questions with seeking answers. It seems like too many folks get stuck on the questions and head straight to the assumption that “if I don’t understand it, it must be bad” and leave it at that, but by asking this question it seems like you are not that type and you genuinely want to learn, so here is what I learned.
You weren’t specific on what exactly is making you nervous, so I’ll share what made me initially nervous, and the answers I found.
I was initially bothered by two questions: 1) how could the vaccines have been developed so quickly, in under a year, when initially al the experts were saying it would take at least 2–3 years and maybe more, and 2) how could they be sure there would be no harmful long-term effects if they were only studying the vaccine for a few months (at the time)?
So I turned to Google and a few people I trust who know their stuff better than me, and it turned out both of my questions had reassuring answers.
1. How did they do it this quick when previous vaccines took years to develop?
I guess first we have to ask why is that vaccines and other drugs take so long to develop and then we can see which corners were cut to arrive at the current covid vaccines.
In general, there are a number of factors that cause the development to take as long as it does.
MONEY
The first, and obvious one is funding. It takes time to secure funding, especially for a drug for which there is no guarantee it will work. Sometimes you finally do secure funding to try a given approach, and after all the research and trials it turns out that approach was a dead end so you now have to start all over again, which can add more delays as you try and secure new funding all over again.
With the covid vaccines, money wasn’t an issue. The world’s governments and philanthropists were pouring money into these vaccines (which makes sense, given the devastation the virus was causing to the world’s economies). This not only shortened the time to get the initial funding but also allowed many different approaches to be tried out in parallel so we didn’t have to waste time with dead ends (which is how we got the situation where we have a number of competing vaccines all at once).
MANPOWER
People-hours is a limited commodity. There are many diseases and conditions that need drugs developed, and only a limited number of researchers are qualified to work on them. During the covid pandemic, however, all of the world’s top minds dropped what they were doing to work on this one problem. Competing labs were sharing data and collaborating. Work that usually had to be done sequentially was able to be done in parallel and a lot of time was saved that way.
RED TAPE
There s a lot of bureaucracy involved in drug development, a lot of forms to push, i’s to dot, t’s to cross, forms to fill in triplicate etc. Many of these steps have to be done in a certain order, so you file the forms for stage A, and only after those get approved can you start the paperwork for stage B etc.
During covid, a lot of the red tape was cut. Things that were there just for the bureaucracy and didn’t actually affect the safety were postponed until after, steps that usually had to be done one after the other were allowed to be done in parallel. This way they were able to cut a lot of time out without sacrificing safety.
TRIAL SUBJECTS
It takes time to recruit enough people for the trials needed to develop a vaccine. During covid, many people were motivated to sign up, either out of a sense of duty and privilege in doing their part in fending the pandemic, or out of the hope that they would be first in line to get the life-saving vaccine. The point is that while a typical study has a few hundred participants, and large ones can have up to 1,500, the trials for the covid vaccines typically had 30–40,000 participants each! So they were able to collect much more data, and of much higher quality.
TIMING
Once you’ve secured funding, filed all the paperwork, signed up participants, given some of them the vaccine and the others a placebo, you now have to wait. You need to wait for enough of them to get infected with the disease you’re trying to protect against to see how many of those infected got the vaccine and how many got the placebo so you can tell if the vaccine offered any real protection.
With most diseases, this wait can take a while, but with covid, because of how prevalent it was and how infectious, it didn’t take more than a few weeks for over a thousand of the study participants to test positive, and seeing how those thousand tended overwhelmingly to be from the placebo group, it gave the researchers confidence that the vaccines were pretty darn effective!
So all of those factors satisfied me that the vaccines, while rushed, had no corners cut and were built on solid data.
But what about question number 2?
2. How do we know there won’t be any rare long-term effects?
The above only tells us that the data from the vaccine trials is solid for the duration of the trials which was about 6–8 months. How do we know there are no ultra-rare and/or long term effects that didn’t show up in the trials do to their size and duration?
I will split this question into two for rare side effects and long term ones:
RARE
The part of the question about rare side effects was easier to get out of the way. As mentioned, the trials were much bigger than typical (30–40,000 participants vs. the 1,500 max they usually get), so any adverse effect that didn’t show up in the trial would have to occur in less than 30,000 people who got the shot. That’s rare enough for the vaccine to be much safer than covid for which almost 15% of people who test positive end up with symptoms sever enough to need hospitalization, and more than half still have symptoms over a year later, so even if there are ultra rare adverse effects, the vaccine is still safer than the disease it’s protect you against.
Note: it’s worth noting, that this has indeed turned out to be the case. Some rare adverse effects did come out a few months after the vaccines were widely available and administered to millions of people, namely the risk of blood clots with the J&J vaccine and heart inflammation with the Pfizer, but, as mentioned, those effects are extremely rare (one in a few hundred thousand doses) and are much more common in people who catch covid.
LONG TERM
But what if there are more common side effects that we just haven’t seen yet because they take months, or even years to manifest?
This part really bothered me, but it turned out that it was based on a misunderstanding. I was under the impression that the reason vaccines usually take so long to approve is because they look for such long-term effects, when the reality is that it takes so long because of all of the reasons already mentioned.
The reality is that long-term effects for a drug or vaccine that’s taken just once (or a few times) aren’t really a thing. There are drugs that have long-term effects that take years to come out, but those are drugs you take regularly for a long time and slowly slowly build up in your system. Any drug that’s taken once and is done with (or at most requires a booster every now and then) typically has side effects that come out soon after the drug was administered.
For vaccines specifically, there are no known side effects from any vaccine that takes more than about a month to come out, and most known effects are seen within an hour of the shot (that is the reason they have you sit at the clinic for 20–30 minutes after your shot).
That is why since the 90s the FDA has only required 10 months of data for for regular vaccine approvals and 6 months for emergency approvals (Frequently Asked Questions about the FDA Drug Approval Process).
The covid vaccines had about 6 months of data in the trials, and by now have data from billions of doses over a period of almost a year. It’s reasonably safe to say that pretty much all of the data in terms of long-term effects is in. Contrast that with covid, where more than half of symptomatic infections still have long term effects over a year later!
All of the above is what convinced me back in March that taking the covid vaccine was safer than the alternative, and that’s why I got my shot. I hope I was able to help you in your decision.
If I did not answer your articular question, feel free to reach out to me and I will see if I can answer any other questions you may have.
